Identity
- Trade Name
- Brasseler USA FDA UDI
- Generic Name
- Rubber dam, non-latex FDA UDI
- Device Name
- TRUE DENTAL DAM LF 6X6 50PK FDA UDI
- Model / Reference
- 838201-B FDA UDI
- Description
- TRUE DENTAL DAM LF 6X6 50PK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887919891710 FDA UDI
- FDA Product Code
- EIE FDA UDI
- GMDN Term
- Rubber dam, non-latex FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rubber dam, non-latex
Brasseler USA by Peter Brasseler Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rubber dam, non-latex.
- Cranberry — ASCEND EAGLE INCORPORATED · Class I
- HEDY DENTAL DAM — AMD Medicom Inc · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Midway Select — MIDWAY DENTAL SUPPLY, LLC · Class I
- Gingival Barrier — ULTRADENT PRODUCTS, INC. · Class I
- HEDY DENTAL DAM — AMD Medicom Inc · Class I
- OpalDam — ULTRADENT PRODUCTS, INC. · Class I
- True™ Dental Dam Latex Free 6x6 — Den-Mat Holdings, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Peter Brasseler Holdings, LLC
Sources (1)
- FDA UDI 68d2d528-f9ec-4901-a43d-270d20ceaaa2 33 fields · synced May 30, 2026